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Artificial Organs - Worldwide Market Challenges & Opportunities
Published on November 2009

                                                                                                                   Report Summary

With decades of research and advances in technology, artificial organs have become the viable alternative to effectively address
donor organ shortage problem. Besides sustaining life and minimizing disease burden, artificial organs have been playing a crucial
role in enhancing patient's quality of life. Additionally, artificial organs are not only enhancing patient outcomes and accelerating
recovery times, but also minimizing overall healthcare expenditure. However, only few implantable devices have been approved for
clinical use, while several others are still in clinical trials awaiting approvals.


With increasing number of patients suffering from late-stage diseases, organ failure has been accounting for the largest chunk of
worldwide medical spending. On the other hand, the rising success rate of transplantation has been dramatically fuelling organ failure
patients to opt for artificial organs. However, as organ recipients continue to rise, patient population on the waiting list is also
expanding. The imbalance between number of receivers and donor organs has compelled the healthcare sector to search for other
alternatives.


These and other market data and trends are presented in "Artificial Organs: Worldwide Market Challenges & Opportunities" by
BizAcumen, Inc. Our reports are designed to be most comprehensive in geographic coverage and vertical market analyses.




                                                                                                                    Table of Content


ARTIFICIAL ORGANSBMR-1017



                                      CONTENTS



 1. METHODOLOGY                                                               1
     Study Reliability and Reporting Limitations                                  1
     Disclaimers                                                  2
     Quantitative Techniques & Reporting Level                                        3


 2. INDUSTRY OVERVIEW                                                             4
     Artificial Organs Revolutionize Medical Technology Industry                          4
     Current and Future Analysis                                          4
     Market Outlook                                                   5
     Opportunities Abound for Bioartificial Organs                                    6
     Bionics to Play Crucial Role                                         6
     Economic Situation Plays a Pivotal Role in ESRD Treatment
      Accessibility                                               7
     Growth Drivers                                                   7



Artificial Organs - Worldwide Market Challenges & Opportunities                                                                        Page 1/7
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     Growth Inhibitors                                                 8


 3. MARKET TRENDS AND ISSUES                                                           9
     Higher Development Costs and Lengthy Regulatory Process -
      Stumbling Blocks- for Product Commercialization                                   9
     Lack of Requisite Expertise - Hindering Implantation Process                            9
     Alliances to Play a Key Role                                           10
     Aging Population - A Boosting Factor                                        10
     Anemia - A Growing Concern among Renal Failure Patients                                      10
     Swelling ESRD Patient Population Spurs Dialyzers Growth                                     10
     Growing Need for Efficient Control and Easy Usage                                      11
     Expiry of Warranty Provides New Opportunities                                     11
     Xenotransplantation - Other Alternative to Donor Organ Shortage                              11
     Artificial Organs from Cloned Animal Cells - A Promising Trend                              11
     Immunosuppressants Hold Promise in Artificial Organs Market                                  12
     Move Towards Smaller Implantable Devices                                          12
     Barriers to Entry Significantly High in Dialyzers Market                          12
     Reuse of Dialyzers - A Major Issue in Dialysis Industry                            12
     Poor Reimbursement Environment Stymies Innovation                                           13
     Pricing Trends in Artificial Organs                                    13


 4. COMPETITIVE SCENARIO                                                          14
     Competition Heating Up in Artificial Pancreas Domain                                   14
     Fresenius Medical Care - Leads the Worldwide Dialysis
      Equipment and Supplies- Market                                             15
     Competitive Landscape of Artificial Kidney or Dialyzers Market                              16
      Synthetic Dialyzers to Attain Mainstay                                     16
      Asahi Kasei Medical Dominates Japanese Dialyzers Market                                     17
     Competitive Landscape of Ventricular Assist Devices                                    18
     Liver Assist Devices Competitive Landscape                                        18


 5. PRODUCT FACTS                                                           19
     Artificial Organs                                             19
      Artificial Heart                                            20
      Artificial Kidneys                                           20
      Artificial Liver                                            20
      Artificial Pancreas                                              20
      Artificial Lungs                                             20
     Organ Rejection - A Major Barrier to Transplantation                               21
     Other Issues for Organ Transplantation                                       21
     Combined Organ Transplantation - Gaining Attention                                     21


 6. REGULATORY ENVIRONMENT                                                              22
     Regulatory Environment in the US                                            22
     Regulatory Environment in Europe                                            23


 7. CORPORATE DEVELOPMENTS                                                              24
     Thoratec Receives FDA Approval for HeartMate II®                                       24
     Asahi Kasei Institutes a Sales Subsidiary in Taiwan                               24
     Arbios Seeks CE Marking for SEPET'                                           25


Artificial Organs - Worldwide Market Challenges & Opportunities                                                                         Page 2/7
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ReportLinker                                                                                                  and Market Statistics


     Gambro Teams up with Debiotech for Developing Peritoneal
      Dialysis Cycler                                             25
     Arbios Obtains US FDA Approval for Initiating Clinical Trial
      for SEPET'                                                  25
     Abiomed Obtains HDE Supplement Approval from FDA for AbioCor
      ®- Implantable Artificial Heart                                       25
     Ventracor Obtains CE Marking for VentrAssist' LVAD                                      26
     Fresenius Medical Care Takes Over Renal Solutions, Inc.                                     26
     Arbios Inks Exclusive Agreement with NxStage for SEPET'                                      26
     WorldHeart Completes First Multi-Day Animal Study of
      PediaFlow' VAD                                                   26
     Xcorporeal Completes Merger with CT Holdings                                           27
     Nikkiso Collaborates with Nipro for Overseas Launch of
      Dialysis Systems                                                 27
     Ege University to Initiate Artificial Heart Project                          27
     Vascutek Buys Kohler Chemie's Heart Valve Business                                          27
     NovaThera Partners with NovaLung to Develop Advanced
      Artificial Lung                                             27
     Aksys Quits Kidney Dialysis Machines Business                                         28
     Twardowski Terminates License Agreement with Aksys                                          28
     Asahi Kasei Medical Fortifies Competence in Artificial Kidney
      Production                                                  28
     Fresenius Medical Care Enhances Dialyzer Output                                        28
     HepaLife Appoints Stem Cell Systems for Bioreactor Development                                    28
     Gambro Unveils AK 96' Dialyzer                                              29
     Nipro Introduces Artificial Kidney Dialyzer in Overseas Markets                             29
     University of Michigan Develops Artificial Lungs                                  29
     USC Researchers Develop Argus II Retinal Prosthesis System for
      Retinal Implant                                              29
     Researchers Develop Cell Manipulation Technique for Organ
      Regeneration- Process                                                 30
     Terumo to Introduce First CE Mark LVAS in Europe                                       30
     Advanced Technique for Nerve Re-Growth Developed                                             30


 8. MAJOR PLAYERS                                                            31
     Abbott Diabetes Care (USA)                                              31
     Abiomed, Inc. (USA)                                                31
     Arbios Systems, Inc. (USA)                                              31
     Asahi Kasei Kuraray Medical Co., Ltd (Japan)                                      31
     Baxter International, Inc. (USA)                                        32
     F.Hoffmann-La Roche Ltd. (Switzerland)                                           32
     Fresenius Medical Care AG & Co. KgaA (Germany)                                              32
      Fresenius Medical Care North America Inc (USA)                                        32
      Fresenius Kawasumi (Japan)                                                 32
     Gambro AB (Sweden)                                                     33
     Hepalife Technologies, Inc. (USA)                                           33
     Jarvik Heart, Inc. (USA)                                           33
     MC3, Inc. (USA)                                                   33
     Medtronic, Inc. (USA)                                              33
     MicroMed Cardiovascular, Inc. (USA)                                          33


Artificial Organs - Worldwide Market Challenges & Opportunities                                                                          Page 3/7
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     Nikkiso Co., Ltd. (Japan)                                    34
     Nipro Corporation (Japan)                                     34
     SynCardia Systems, Inc. (USA)                                      34
     Terumo Corporation (Japan)                                        34
     Thoratec Corporation (USA)                                        35
     Toray Medical Co., Ltd. (Japan)                                   35
     Ventracor Limited (Australia)                                 35
     Vital Therapies, Inc. (USA)                                  35
     WorldHeart Corporation (USA)                                       35


 9. GLOBAL MARKET ANALYTICS                                                  36



EXHIBITS


     Table 1: Percentage Breakdown of Leading Players in the
     Worldwide Dialysis Equipment and Supplies Market by Sales-
     2006


     Table 2: Percentage Breakdown of Leading Players in the
     Worldwide Hemodialysis Equipment and Supplies Market by Sales
     - 2006


     Table 3: Percentage Breakdown of Leading Players in the
     Worldwide Peritoneal Dialysis Equipment and Supplies Market by
     Sales - 2006


     Table 4: Percentage Breakdown of Leading Players in the
     Worldwide Dialyzers Market by Unit Output - 2007


     Table 5: Percentage Breakdown of Leading Players in the
     Japanese Kidney Dialyzers Market by Sales - 2006


     Table 6: Percentage Breakdown of Leading Players in the
     Worldwide VADs Market by Sales - 2006


     Table 7: Global Artificial Organs Market by Product Segment
     for the Period 2007-2015 (Sales in US$ Million)


     Table 8: Percentage Breakdown of Global Artificial Organs
     Market by Product Segment for the Years 2008 & 2012


     Table 9: Global Artificial Kidneys/Dialyzers Market by Region
     for the Period 2007-2015 (Sales in US$ Million)


     Table 10: Percentage Breakdown of Global Artificial
     Kidneys/Dialyzers Market by Region for the Years 2008 & 2012


     Table 11: Global Insulin Pumps (External) Market by Region for
     the Period 2007-2015 (Sales in US$ Million)


Artificial Organs - Worldwide Market Challenges & Opportunities                                                     Page 4/7
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     Table 12: Percentage Breakdown of Global Insulin Pumps
     (External) Market by Region for the Years 2008 & 2012



COMPANIES PROFILED




Artificial Organs - Worldwide Market Challenges & Opportunities                                     Page 5/7
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Artificial Organs - Worldwide Market Challenges & Opportunities

  • 1. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! Artificial Organs - Worldwide Market Challenges & Opportunities Published on November 2009 Report Summary With decades of research and advances in technology, artificial organs have become the viable alternative to effectively address donor organ shortage problem. Besides sustaining life and minimizing disease burden, artificial organs have been playing a crucial role in enhancing patient's quality of life. Additionally, artificial organs are not only enhancing patient outcomes and accelerating recovery times, but also minimizing overall healthcare expenditure. However, only few implantable devices have been approved for clinical use, while several others are still in clinical trials awaiting approvals. With increasing number of patients suffering from late-stage diseases, organ failure has been accounting for the largest chunk of worldwide medical spending. On the other hand, the rising success rate of transplantation has been dramatically fuelling organ failure patients to opt for artificial organs. However, as organ recipients continue to rise, patient population on the waiting list is also expanding. The imbalance between number of receivers and donor organs has compelled the healthcare sector to search for other alternatives. These and other market data and trends are presented in "Artificial Organs: Worldwide Market Challenges & Opportunities" by BizAcumen, Inc. Our reports are designed to be most comprehensive in geographic coverage and vertical market analyses. Table of Content ARTIFICIAL ORGANSBMR-1017 CONTENTS 1. METHODOLOGY 1 Study Reliability and Reporting Limitations 1 Disclaimers 2 Quantitative Techniques & Reporting Level 3 2. INDUSTRY OVERVIEW 4 Artificial Organs Revolutionize Medical Technology Industry 4 Current and Future Analysis 4 Market Outlook 5 Opportunities Abound for Bioartificial Organs 6 Bionics to Play Crucial Role 6 Economic Situation Plays a Pivotal Role in ESRD Treatment Accessibility 7 Growth Drivers 7 Artificial Organs - Worldwide Market Challenges & Opportunities Page 1/7
  • 2. Find Industry reports, Company profiles ReportLinker and Market Statistics Growth Inhibitors 8 3. MARKET TRENDS AND ISSUES 9 Higher Development Costs and Lengthy Regulatory Process - Stumbling Blocks- for Product Commercialization 9 Lack of Requisite Expertise - Hindering Implantation Process 9 Alliances to Play a Key Role 10 Aging Population - A Boosting Factor 10 Anemia - A Growing Concern among Renal Failure Patients 10 Swelling ESRD Patient Population Spurs Dialyzers Growth 10 Growing Need for Efficient Control and Easy Usage 11 Expiry of Warranty Provides New Opportunities 11 Xenotransplantation - Other Alternative to Donor Organ Shortage 11 Artificial Organs from Cloned Animal Cells - A Promising Trend 11 Immunosuppressants Hold Promise in Artificial Organs Market 12 Move Towards Smaller Implantable Devices 12 Barriers to Entry Significantly High in Dialyzers Market 12 Reuse of Dialyzers - A Major Issue in Dialysis Industry 12 Poor Reimbursement Environment Stymies Innovation 13 Pricing Trends in Artificial Organs 13 4. COMPETITIVE SCENARIO 14 Competition Heating Up in Artificial Pancreas Domain 14 Fresenius Medical Care - Leads the Worldwide Dialysis Equipment and Supplies- Market 15 Competitive Landscape of Artificial Kidney or Dialyzers Market 16 Synthetic Dialyzers to Attain Mainstay 16 Asahi Kasei Medical Dominates Japanese Dialyzers Market 17 Competitive Landscape of Ventricular Assist Devices 18 Liver Assist Devices Competitive Landscape 18 5. PRODUCT FACTS 19 Artificial Organs 19 Artificial Heart 20 Artificial Kidneys 20 Artificial Liver 20 Artificial Pancreas 20 Artificial Lungs 20 Organ Rejection - A Major Barrier to Transplantation 21 Other Issues for Organ Transplantation 21 Combined Organ Transplantation - Gaining Attention 21 6. REGULATORY ENVIRONMENT 22 Regulatory Environment in the US 22 Regulatory Environment in Europe 23 7. CORPORATE DEVELOPMENTS 24 Thoratec Receives FDA Approval for HeartMate II® 24 Asahi Kasei Institutes a Sales Subsidiary in Taiwan 24 Arbios Seeks CE Marking for SEPET' 25 Artificial Organs - Worldwide Market Challenges & Opportunities Page 2/7
  • 3. Find Industry reports, Company profiles ReportLinker and Market Statistics Gambro Teams up with Debiotech for Developing Peritoneal Dialysis Cycler 25 Arbios Obtains US FDA Approval for Initiating Clinical Trial for SEPET' 25 Abiomed Obtains HDE Supplement Approval from FDA for AbioCor ®- Implantable Artificial Heart 25 Ventracor Obtains CE Marking for VentrAssist' LVAD 26 Fresenius Medical Care Takes Over Renal Solutions, Inc. 26 Arbios Inks Exclusive Agreement with NxStage for SEPET' 26 WorldHeart Completes First Multi-Day Animal Study of PediaFlow' VAD 26 Xcorporeal Completes Merger with CT Holdings 27 Nikkiso Collaborates with Nipro for Overseas Launch of Dialysis Systems 27 Ege University to Initiate Artificial Heart Project 27 Vascutek Buys Kohler Chemie's Heart Valve Business 27 NovaThera Partners with NovaLung to Develop Advanced Artificial Lung 27 Aksys Quits Kidney Dialysis Machines Business 28 Twardowski Terminates License Agreement with Aksys 28 Asahi Kasei Medical Fortifies Competence in Artificial Kidney Production 28 Fresenius Medical Care Enhances Dialyzer Output 28 HepaLife Appoints Stem Cell Systems for Bioreactor Development 28 Gambro Unveils AK 96' Dialyzer 29 Nipro Introduces Artificial Kidney Dialyzer in Overseas Markets 29 University of Michigan Develops Artificial Lungs 29 USC Researchers Develop Argus II Retinal Prosthesis System for Retinal Implant 29 Researchers Develop Cell Manipulation Technique for Organ Regeneration- Process 30 Terumo to Introduce First CE Mark LVAS in Europe 30 Advanced Technique for Nerve Re-Growth Developed 30 8. MAJOR PLAYERS 31 Abbott Diabetes Care (USA) 31 Abiomed, Inc. (USA) 31 Arbios Systems, Inc. (USA) 31 Asahi Kasei Kuraray Medical Co., Ltd (Japan) 31 Baxter International, Inc. (USA) 32 F.Hoffmann-La Roche Ltd. (Switzerland) 32 Fresenius Medical Care AG & Co. KgaA (Germany) 32 Fresenius Medical Care North America Inc (USA) 32 Fresenius Kawasumi (Japan) 32 Gambro AB (Sweden) 33 Hepalife Technologies, Inc. (USA) 33 Jarvik Heart, Inc. (USA) 33 MC3, Inc. (USA) 33 Medtronic, Inc. (USA) 33 MicroMed Cardiovascular, Inc. (USA) 33 Artificial Organs - Worldwide Market Challenges & Opportunities Page 3/7
  • 4. Find Industry reports, Company profiles ReportLinker and Market Statistics Nikkiso Co., Ltd. (Japan) 34 Nipro Corporation (Japan) 34 SynCardia Systems, Inc. (USA) 34 Terumo Corporation (Japan) 34 Thoratec Corporation (USA) 35 Toray Medical Co., Ltd. (Japan) 35 Ventracor Limited (Australia) 35 Vital Therapies, Inc. (USA) 35 WorldHeart Corporation (USA) 35 9. GLOBAL MARKET ANALYTICS 36 EXHIBITS Table 1: Percentage Breakdown of Leading Players in the Worldwide Dialysis Equipment and Supplies Market by Sales- 2006 Table 2: Percentage Breakdown of Leading Players in the Worldwide Hemodialysis Equipment and Supplies Market by Sales - 2006 Table 3: Percentage Breakdown of Leading Players in the Worldwide Peritoneal Dialysis Equipment and Supplies Market by Sales - 2006 Table 4: Percentage Breakdown of Leading Players in the Worldwide Dialyzers Market by Unit Output - 2007 Table 5: Percentage Breakdown of Leading Players in the Japanese Kidney Dialyzers Market by Sales - 2006 Table 6: Percentage Breakdown of Leading Players in the Worldwide VADs Market by Sales - 2006 Table 7: Global Artificial Organs Market by Product Segment for the Period 2007-2015 (Sales in US$ Million) Table 8: Percentage Breakdown of Global Artificial Organs Market by Product Segment for the Years 2008 & 2012 Table 9: Global Artificial Kidneys/Dialyzers Market by Region for the Period 2007-2015 (Sales in US$ Million) Table 10: Percentage Breakdown of Global Artificial Kidneys/Dialyzers Market by Region for the Years 2008 & 2012 Table 11: Global Insulin Pumps (External) Market by Region for the Period 2007-2015 (Sales in US$ Million) Artificial Organs - Worldwide Market Challenges & Opportunities Page 4/7
  • 5. Find Industry reports, Company profiles ReportLinker and Market Statistics Table 12: Percentage Breakdown of Global Insulin Pumps (External) Market by Region for the Years 2008 & 2012 COMPANIES PROFILED Artificial Organs - Worldwide Market Challenges & Opportunities Page 5/7
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